Roche announced positive results from the phase III GADOLIN study, which evaluated treatment options for people with indolent non-Hodgkin’s lymphoma (iNHL) who are refractory to MabThera/Rituxan (rituximab) treatment. At a pre-planned interim analysis, an independent data monitoring committee determined that the study met its primary endpoint early. The study showed that people lived significantly longer without disease worsening or death (progression-free survival, PFS) when treated with Gazyva (obinutuzumab) plus bendamustine followed by Gazyva alone, compared to bendamustine alone. The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected adverse events with Gazyva.
“GADOLIN is the first of our pivotal phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukaemia,” says Sandra Horning, MD, Roche’s chief medical officer and Head of Global Product Development. “We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential in combination with bendamustine for people whose MabThera/Rituxan-based therapy failed to adequately control their disease.”
Data from this pivotal study will be submitted for presentation at an upcoming medical meeting and to the US Food and Drug Administration, European Medicines Agency and other health authorities around the world for approval consideration.
GADOLIN (NCT01059630; GA04753g) is a phase III open-label, multicenter, randomized two-arm study evaluating Gazyva plus bendamustine followed by Gazyva alone for up to two years compared to bendamustine alone in 413 patients with indolent non-Hodgkin’s lymphoma whose disease progressed during or following MabThera/Rituxan-based therapy. The primary endpoint of the study is PFS, with secondary endpoints including response rate (RR), best response and overall survival (OS).
Gazyva, marketed as Gazyvaro in the EU and Switzerland, is a monoclonal antibody designed to attach to CD20, a protein found only on the surface of B-cells. It attacks and destroys targeted cells both directly and together with the body's immune system.
Gazyva was discovered by Roche Innovation Center Zurich, formerly Roche Glycart AG, a wholly owned, independent research unit of Roche. In the US, Gazyva is part of a collaboration between Genentech and Biogen Idec.
Gazyva/Gazyvaro is currently approved in more than 40 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia. Gazyva continues to be investigated in a large clinical programme, which includes the head-to-head Phase III GOYA study compared to MabThera/Rituxan plus chemotherapy in first line diffuse large B-cell lymphoma (DLBCL) and the head-to-head Phase III GALLIUM study compared to MabThera/Rituxan plus chemotherapy in first line indolent non-Hodgkin’s lymphoma. Additional combination studies with small molecule biologic modifiers are planned or underway across a range of blood cancers.
There are two main types of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL). NHL has two subsets, aggressive and indolent. NHL represents approximately 85 per cent of all lymphomas diagnosedi and was responsible for approximately 200,000 annual deaths worldwide in 2012i.
B-lymphocytes are cells that are part of the body’s immune system and help to defend the body against infections. B-cell lymphoma develops when these cells become cancerous and begin to multiply and collect in the lymph nodes or lymphatic tissues such as the spleen.